INTRAOP MEDICAL CORP.

FDA Device Registration & Listing · Fremont, CA, US · Registration 2953704

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2953704
FEI Number
3001874253
Entity Name
INTRAOP MEDICAL CORP.
City/State/Country
Fremont, CA, US
Establishment Address
448 Kato Ter, Fremont, CA 94539, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
INTRAOP MEDICAL CORP. (Owner Number: 9011205)
Owner / Operator Contact Address
448 Kato Terrace, --, Fremont, CA 94539, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K981112
PMA Number
N/A

All Registered Proprietary Names

MOBETRON

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2008-01-24

Official Correspondent

Indu Lakshman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTRAOP MEDICAL CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2009 Intraop Medical Corporation 2
Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2953704. Last updated year: 2026. Please use registration number 2953704 when referencing this establishment in official correspondence.
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